On December 28, 2025, a new final rule from the FDA regarding medical gases will take effect. This rule aims to update and clarify the regulations surrounding current good manufacturing practices (CGMP), post-marketing safety reporting, and labeling for medical gases, while also establishing specific certification requirements for these products.

Background

Medical gases, unlike other drugs, require tailored regulations due to their unique characteristics. Recognizing this, the FDA issued a proposed rule on May 23, 2022, to address these needs. The rule, now finalized, seeks to amend the CGMP, post-marketing safety reporting, and labeling requirements for certain medical gases, as well as to establish a clear certification process for these products. This initiative stems from the need to ensure that the regulatory framework for medical gases is both efficient and effective, promoting safety and quality in their manufacture and use.

Summary of New Regulations

The new regulations encompass four main areas: CGMP, certifications, post-marketing safety reporting, and labeling. Here’s a detailed summary of each:

Current Good Manufacturing Practices (CGMP)

The final rule introduces specific CGMP regulations for medical gases, aligning them closely with the general drug CGMP regulations but with necessary adjustments. Key provisions include:

• Requirements for gas containers and closures similar to those for general drug products.
• Mandates for cryogenic medical gas containers and containers used by individual patients to include a gauge indicating when a refill is needed.
• Special cleaning requirements, reflecting that medical gases are manufactured in a sealed, closed system.
• Provisions allowing salvaging of improperly stored medical gases provided the container integrity is maintained.

Certifications

The certification process for designated medical gases is now more streamlined and clear, including:

• A simplified annual reporting process, switching from an anniversary date to a calendar year basis.
• Specific requirements for filing certification requests and transferring ownership of certifications.

Post-Marketing Safety Reporting

The final rule significantly revises the post-marketing safety reporting requirements, including:

• Extended timelines for Field Alert Reports (FARs) from 3 business days to 45 calendar days.
• Mandatory reporting of serious adverse events for human and animal use gases within 15 calendar days.
• Requirement for electronic submission of reports, with provisions for requesting a waiver.

Labeling

Labeling requirements have been standardized to ensure consistency and safety, including:

• Standardized format for all designated medical gases used for humans, animals, or both.
• Specific warning statements for medical air, carbon monoxide, and oxygen containers.
• Inclusion of the owner’s information on gas containers to facilitate returns and address quality issues.

What Does This Mean For Industry?

The final rule introduces several significant changes impacting the medical gas industry. Most notably, the extended reporting timelines for Field Alert Reports (now 45 calendar days), the mandatory electronic submission of post-marketing safety reports, and the standardized annual reporting for certifications represent major shifts. These changes require manufacturers to upgrade their reporting systems and processes, which could be disruptive and costly. Additionally, the new CGMP regulations, including the requirement for gauges on cryogenic containers, and standardized labeling, impose stricter compliance standards, increasing the need for rigorous oversight and potentially leading to higher operational costs.

How Can I Be Prepared?

To ensure compliance with the new regulations, industry stakeholders should:

1. Read the Full Final Rule: Understanding the details of the new regulations is crucial for effective implementation.
2. Perform a Gap Analysis: Identify areas where current practices do not align with the new requirements and develop a plan to address these gaps.
3. Reach Out to Experts: Contact dicentra for comprehensive services and support in navigating these regulatory changes.

By proactively addressing these changes, companies can ensure a smooth transition to the new regulatory framework, maintaining high standards of safety and quality in the production and distribution of medical gases.